search
Back to results

Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter (REDUCE AF)

Primary Purpose

Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CTI ablation alone
CTI ablation and Pulmonary vein isolation (PVI)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typical Atrial Flutter focused on measuring typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study.

Risk factors for predicting future occurrence of AF will include:

  1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
  2. LA size > 4.0 cm,
  3. left ventricular ejection fraction (LVEF) ≤ 50%,
  4. hypertension, and/or 5) obstructive sleep apnea.

Exclusion Criteria:

  1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
  2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
  3. failure to provide informed consent.

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

CTI ablation only

CTI ablation and PVI.

Arm Description

subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter

subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.

Outcomes

Primary Outcome Measures

Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).

Secondary Outcome Measures

Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death

Full Information

First Posted
October 11, 2012
Last Updated
April 28, 2017
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT01710150
Brief Title
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
Acronym
REDUCE AF
Official Title
Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Detailed Description
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter
Keywords
typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CTI ablation only
Arm Type
Placebo Comparator
Arm Description
subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
Arm Title
CTI ablation and PVI.
Arm Type
Active Comparator
Arm Description
subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
Intervention Type
Procedure
Intervention Name(s)
CTI ablation alone
Intervention Type
Procedure
Intervention Name(s)
CTI ablation and Pulmonary vein isolation (PVI)
Primary Outcome Measure Information:
Title
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study. Risk factors for predicting future occurrence of AF will include: prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation), LA size > 4.0 cm, left ventricular ejection fraction (LVEF) ≤ 50%, hypertension, and/or 5) obstructive sleep apnea. Exclusion Criteria: Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment, inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and failure to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Dixit, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25884325
Citation
Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.
Results Reference
derived

Learn more about this trial

Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter

We'll reach out to this number within 24 hrs